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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name catheter, retention type, balloon
510(k) Number K091767
Device Name 3 WAY SILICONE FOLEY BALLOON CATHETER
Applicant
COOK UROLOGICAL, INC.
1100 WEST MORGAN ST.
SPENCER,  IN  47460
Applicant Contact BRENDA DAVIS
Correspondent
COOK UROLOGICAL, INC.
1100 WEST MORGAN ST.
SPENCER,  IN  47460
Correspondent Contact BRENDA DAVIS
Regulation Number876.5130
Classification Product Code
EZL  
Date Received06/17/2009
Decision Date 10/09/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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